Monitoring Anticoagulant Therapy in Antiphospholipid Syndrome

Monitoring Anticoagulant Therapy With Vitamin-K Antagonists in Patients With Antiphospholipid Syndrome

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01660061

Enrollment

150

Registered

2012-08-08

Start date

2011-07-31

Completion date

2014-12-31

Last updated

2015-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antiphospholipid Syndrome

Keywords

Antiphospholipid syndrome, Antiphospholipid antibodies, Vitamin-K antagonists, International normalized ratio, Chromogenic factor X

Brief summary

To Assess the Influence of Antiphospholipid Antibodies on INR Test Results in Patients with the Antiphospholipid Syndrome Anticoagulated with Vitamin-K Antagonists.

Detailed description

Patients with an antiphospholipid syndrome receiving Vitamin-K antagonists for secondary prevention after a first thrombotic complication are known to be at higher risk of recurrent thrombotic events despite INR values in the therapeutic range. It ist also known that antiphospholipid antibodies can interfere with phospholipid-dependent tests (e.g. prothrombin time and INR). The primary objective of this study is to determine the prevalence of interfering antiphospholipid antibodies. The intensity of anticoagulant therapy was assessed by measuring the INR using different thromboplastins and the CoaguChek system for INR self-assessment. Test results were compared to measurements of the phospholipid-independent chromogenic factor X. The second objective of this study is to evaluate the incidence of recurrent thrombotic events during 1-year follow-up.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

Inclusion criteria

* age 18-90 years

Exclusion criteria

* none

Design outcomes

Primary

Measure	Time frame
Difference between INR and CFX correlate >20%	0, 1, 2, 3, 6 and 12 month

Secondary

Measure	Time frame	Description
Arterial or venous thrombosis	12 months	Any arterial of venous thrombosis occurring under anticoagulant treatment with vitamin-K antagonists during 1-year follow-up

Countries

Germany

Outcome results